Minnesota Lawmakers Want Answers From FDA On Med Devices

Lawmakers from the state of Minnesota, where some 400 medical technology companies are headquartered, have added to the chorus of voices claiming that undue delays by the Food and Drug Administration have stifled innovation and caused a number of young companies to close up shop or move overseas.

Reuters

But the agency says the companies themselves make mistakes that add to delays and costs.

In a letter to FDA Commissioner Margaret Hamburg, Sens. Amy Klobuchar and Al Franken and U.S. Reps. Erik Paulsen, Collin Peterson, John Kline, Betty McCollum, Keith Ellison, Michele Bachmann, Tim Walz and Chip Cravaack asked for an explanation from the agency for a recent, steep drop in approvals for Investigational Device Exemptions.

IDEs are a precursor to getting new medical devices approved. In the IDE process, regulators tell applicants what types of clinical data will be necessary before moving forward with a consideration for approval.

The lawmakers’ letter to the agency said IDEs approved in an applicant’s first go-around with the agency dropped by 43% from 2009 to 2010, continuing a decade-long decline. That means that a much larger number of applicants are being sent back to the drawing board before getting clear guidance on what the FDA will require.

The letter echoes issues raised in a recent VentureWire exclusive, which cited complaints lodged by the Medical Device Venture Council, a group of life sciences investors from nine prominent venture firms who claim that unwarranted delays in the IDE and other processes is forcing their portfolio companies into shutting down or moving to Europe.

The FDA, which has experienced pressures related to staff turnover and budget fluctuations, has acknowledged that it may need to tighten up some aspects of its approval process.

But the agency also puts much of the onus back on industry, saying applicants often submit shoddy applications, or propose poorly designed studies of their technology.

“Failure to get it right up front leads to wasted time and money on the part of companies and the FDA, delays product approvals (if approval is warranted) and exposes patients to unnecessary risks by participating in clinical studies that are of no, or limited, value,” a statement from the agency said.

Addressing criticism of its IDE process and subsequent approval processes, the agency listed a number of common problems that cause regulators to put the brakes on.

Applicants often have trouble adequately describing their device, the FDA said. Applications are also often lacking predicate comparisons, which are needed if the proposed device resembles another device already on the market, according to the statement.

Applicants often leave off biocompatibility information, the FDA said. Instructions on how the device is to be used are also frequently missing.

In the 510(k) process –- for devices that have a predicate already on the market –- 60% of submissions receive two or more requests from the FDA for additional information, often because they do not address guidance documents, according to Christy Foreman, director of the FDA’s Office of Device Evaluation.

The agency said that, in a minority of cases, regulators add to delays by asking for information that is later shown to be irrelevant to the case at hand.

But that is in a slim minority of cases, the agency said in another statement.

“ … Total review times have either remained the same or increased for many applicants primarily due to industry conducting poor-quality clinical studies or submitting poor quality applications, including those that don’t follow current guidance or provide an alternative approach or don’t provide any performance data when such testing has been conducted for that device in the past,” the statement said. “Expending agency resources on poor quality submissions creates unnecessary inefficiencies.”

Comments (4 of 4)

I have a Sensor Pad. I am a woman in my middle fifities. I have had my Sensor Pad for approximately 20 years. I am getting ready to pass it down to my daughter. I am at best disappointed, but not surprised at the FDA's ridiculous position on this device. It is another example of a truly effective, possible live saving product being buried under the bureacracy of double talk until a 'greater economic opportunity' surfaces...(right after the current patent expires). The FDA's logic that women would forgo their mammograms is rediculous! Women who have MEDICAL INSURANCE get their mammograms regularly. The medical standard now is for women is certain categories to get the mammogram annualy. If this is the standard, why should women do a monthly exam? Why not let the technolgy make the diagnosis? At the same time, the marketing campaigns want women to self exam. Why then, won't the FDA give them a device that helps them do that??? As to the issue of the device leaking - ANY product that contains a liquid and is mishandled will break or leak. Even mercury filled thermometers did. And look how long the FDA kept those on the market. Did people die ? Only the stupid ones... (who mishandled and broke them and used them anyway.) We're not even talking about a hazardous material. It's silicon! (maybe they are afraid that the women's breats might absorb the material and get a little 'boost' for free). Let the lawyers do what they do and write the usual product liability disclaimer on the package or better - a 'use at you own risk' diclaimer and give women a choice. This unfortunately is all about money. Which entity is it that is keeping this product off the market?

2:08 pm July 18, 2011

Jesse_EngAmer wrote:

Thank you for the response. I wasn't aware of this information and I apologize for not responding swiftly. You make an excellent point. Yet my point remains. To quote the FDA: "Class III devices are high risk devices that pose a significant risk of illness or injury." The Sensor Pads cannot be argued through any measure of common sense as posing a significant risk of illness or injury. While the FDA may have argued that people would forgo a mammogram, the fact remains is that the Sensor Pad is an effective product and was responsible for saving the lives of many women. While perhaps it would have been important that the Sensor Pad was marketed in such a way that women were well informed of the importance of mammogram, that is a marketing issue. Furthermore, that would be a disclaimer, something required of all medical devices and pharmaceuticals. In this specific example the FDA delayed a device that needn't had been delayed. It is not the only example in history.

3:17 pm July 6, 2011

Harvey Wiley wrote:

That's not the whole story re Breast Sensor Pads. FDA was concerned that a woman might use a Breast Sensor Pad and forgo a mammogram which could diagnose early stage cancer in a way that the Breast Sensor Pad cannot. FDA's position was vinidicated in the 7th Circuit Federal Appeals Court in 1991. See 942 F 2d 1179. Inventive Products argued uncovincingly that the Breast Sensor Pad was not a medical device.

11:28 am July 6, 2011

Jesse_EngAmer wrote:

The FDA’s system for approving medical devices is inefficient and ineffective. Let’s not forget the Sensor pad fiasco.

With the Medical Device Amendments, Medical devices came under official FDA control in 1976 leading to an increase in delays and cost associated with medical devices. A perfect example is the Sensor Pad invented in 1986 by Earl Wright of Inventive Products. “The FDA, however, could find no other substantially equivalent product on the market and thus automatically classified the Sensor Pad as a high-risk, Class III device.”

The Sensor Pad is nothing more than sealed plastic with a silicon lubricant that allows women to easily detect unusual breast lumps in a self-examination.

It took hundreds of pages of documentation proving its safety and effectiveness, a lawsuit and a media firestorm to approve the Sensor Pad and many years. But only with a doctor’s prescription.

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